Body Dysmorphic Disorder: Pharmacological enhancement of fear extinction; a randomized placebo controlled, double blind study.

Phase 2

Conditions: Body Dysmorphic Disorder
10077546

Registration Number: NL-OMON33898

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- All patients meet the DSM-IV criteria for BDD
- Male and female, aged between 18-65 years
- Female patients of childbearing potential must have a negative pregnancy test and use reliable method of contraception.
- Written informed consent
- Eligible for exposure therapy
- Right-handed

Exclusion Criteria

Presence of any of the following DSM IV conditions:
* Major depression (HDRS * 15)
* Bipolar Disorder
* Schizophrenia or any other psychotic disorder
* Tic disorder
* Substance related disorder during the past 6 months
* Epilepsy or any structural CNS disorder of stroke within the last year;- Presence of primary or co-morbid personality disorder
- Evidence of clinically significant and unstable cardiovascular, gastrointestinal, pulmonary, Renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within de past year or micturition abnormalities.
- Currently taking benzodiazepines
- Patients at risk for suicide
- Multiple serious drug allergies of known allergy for DCS
- Inability to speak Dutch or English

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in BDD-Yale Brown Obsessive Compulsive Scale (BDD-YBocs) and time of<br /><br>onset of change on the BDD-YBOCS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>VLGT : Verbal Learning and Memory Test<br /><br>WCST: Wisconsin Card Sorting Test<br /><br>TOL: Tower of London<br /><br>ET: Extinction Task<br /><br>CGI: Clinical Global Impression scale<br /><br>BABS: Brown Assessment of Belief Scale<br /><br>HDRS: Hamilton Depression Rating Scale<br /><br>HARS: Hamilton Anxiety Rating Scale<br /><br>SDS: Sheehan Disability Scales<br /><br>WHOQOL World Health Organization Quality of Life</p><br>